Refocus Group Hires CEO

Refocus Group Inc. has a new leader.

The Dallas, Texas-based company recently appointed Michael (Mike) Judy president and CEO. Judy, a 30-year veteran in refractive and ophthalmic device sales and marketing, most recently was chief commercialization officer at AcuFocus Inc., where he supervised global sales and marketing, and interfaced with manufacturing, research and development, and clinical and regulatory personnel to ensure rapid growth.

Former CEO Doug Williamson has assumed a new board level role within the company and is helping Judy during his first weeks and months as chief executive.

Before he worked for AcuFocus, Judy served as vice president, global marketing for Bausch & Lomb and was responsible for setting strategic direction for the company’s global surgical business. His background in marketing and sales also has included leadership positions with Eyeonics, Allergan’s IOL Surgical division (now a part of Abbott Medical Optics), and Pharmacia.

“I have been impressed with the progress made by Refocus underpinned by some exciting and impressive clinical results; I welcome this opportunity to contribute to the company’s future advancement. The presbyopia correction market is significant with 110 million presbyopes in the United States, and 1.7 billion worldwide,” Judy said. “The presbyopia market has many of the attributes of the early LASIK correction market, which saw dramatic growth in refractive procedures when laser technology was first launched in the 1990’s – growth that continues on a global basis to this day. I believe that Refocus is well positioned to take advantage of the demand for a dynamic binocular solution for presbyopia, and I look forward to helping the team exploit the value of its unique technology.”

Glen Bradley, Chairman of the Board at Refocus, said: “I am very pleased to welcome Mike to Refocus. His significant experience in building successful ophthalmology companies will prove invaluable as Refocus begins its next stage of development. Mike will play a pivotal role in helping us submit our presbyopia treatment for FDA approval and in continuing to commercialize the treatment throughout Europe.”

Refocus Group’s main product is the Refocus Scleral Implant used in a revolutionary extra-ocular procedure to restore near vision, which reduces or eliminates the need for reading glasses in the near emmetrope, presbyopic patient. Refocus Group currently is conducting a pivotal U.S. Food and Drug Administration (FDA) Investigational Device Exemption clinical trial in the United States, and completed enrollment of a 330-patient FDA cohort in October of 2012. Refocus’ products bear the CE Mark in the European Union with early commercialization having begun this year. In support of that marketing launch, Refocus also has started a multi-center clinical study for the treatment of presbyopia in key centers throughout the European Union. In addition, Refocus has ongoing clinical studies in Europe to further substantiate the benefits of the Refocus procedure for early stage glaucoma and ocular hypertensive patients.

“Since I joined Refocus in late 2011, we have seen remarkable improvements in the Refocus surgical technique which have made the procedure more precise, faster, and more comfortable for the patient. We have finished recruitment for the FDA pivotal study for presbyopia, and are completing data collection for the two-year follow-up,” said David Schanzlin, chief investigative officer for Refocus. “We are on target to meet and/or exceed the primary endpoints for the FDA study. We believe the Refocus procedure is uniquely positioned against other surgical procedures for the presbyopic patient, as it is extra-ocular and entirely outside of the visual axis, eliminating any loss of distance vision, or halos, starbursts, or ghost images. The procedure is also binocular, so there is no loss of depth perception or contrast sensitivity. The addition of Mike Judy as CEO of Refocus should accelerate the broader understanding and benefits of the Refocus procedure, and facilitate acceptance of Refocus as one of the leading providers of solutions for presbyopia worldwide.”

“As we finish our two year follow-up and approach the filing of the final modules in the FDA IDE approval process, the knowledge Mike has of the intricacies of the submission process will be invaluable,” added Barrie Soloway, Medical Director at Refocus.

Refocus Group develops treatments for human vision disorders. The company’s aims to become the preferred surgical alternative for the treatment of presbyopia in pre-cataract patients.